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Pharmacovigilance (PV)

Pharmacovigilance (PV). Pharmacovigilance (PV). PV is concerned with detection , assessment & prevention of adverse reactions to drugs (ADRs) or any drug-related problems. 2. Drug-Related Problems. Lack of efficacy. Manufacturing defects. Medication errors. Drug misuse and abuse.

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Pharmacovigilance (PV)

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  1. Pharmacovigilance (PV)

  2. Pharmacovigilance (PV) • PVis concerned withdetection, assessment & prevention of adverse reactions to drugs (ADRs) or any drug-related problems 2

  3. Drug-Related Problems • Lack of efficacy. • Manufacturing defects. • Medication errors. • Drug misuse and abuse. • Overdose. • Contamination. • Counterfeit products. 3

  4. Recently, the concerns of PV have been widened to include: • Herbal • Traditional and complementary medicines • Blood products • Biologicals • Medical devices • Vaccines 4

  5. Why Pharmacovigilance? • The root of pharmacovigilance: Pharmaco (Greek)= Drug Vigilance (Latin)= to keep awake or alert • Because information collected during pre-marketing phase are incomplete with regard to possible ADR • Tests in animals are insufficiently predictive of human safety

  6. Why Pharmacovigilance? 6 • In clinical trials: • Patients are limited in number • Conditions of use differ from those in clinical practice • Duration of trials is limited

  7. Why Pharmacovigilance? Post-marketing surveillance by companies is therefore essential • Information about rare adverse reactions, chronic toxicity, use in special groups (children, elderly or pregnant women) or drug interactions is often incomplete or not available

  8. Why Pharmacoviglance? • Pre-marketing clinical trialsdo not have : • Statistical power to detect rare ADRs • To identify delayed ADRs • To identify effects from long-term exposure PV plays a prominent role in establishing safety profile of marketed drugs 8

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  10. Definition of ADR • An ADRis defined according to definition of WHO“any response to a drug which is noxious, unintended& thatoccurs at dosesused in man for prophylaxis, diagnosis, or therapy of diseases’’ 10

  11. Epidemiology of ADRs ADRs represent a significant cause ofmorbidity & mortality Many ADRs aremild, sometimesserious& cancause death U.S, ADRs caused100 000deaths per year, 4th & 6thleading cause of death About 50% of ADRs are preventable 11

  12. Importance of ADRs Prolonglength of stay in hospitals Increasecostsof patient care Commonest cause ofdrug withdrawal from market: Reductil (Sibutramine) 2010 Valdecoxib (Bextra) 2005 Rofecoxib (Vioxx) 2004 12

  13. ADRs is considered serious if: Causesdeath of patient Life-threatening Prolonginpatient hospitalisation Causessignificant or persist disability Congenital abnormality 13

  14. Risk Factors predisposing to ADRs • Age • Long duration of treatment • Polypharmacy • Liver, kidney diseases

  15. Causes of ADRs • Patient • Drug • Prescriber • Environmental factors

  16. Causes of ADRs 2. The drug - Narrow therapeutic index, e.g. warfarin, digoxin - Antimicrobials have a tendency to cause allergy - Ingredients of a formulation, e.g. colouring, flavouring 16

  17. Drugs most commonly causing ADRs • Warfarin • Diuretics • Digoxin • Antibacterials • Steroids • Antihypertensives Anticancer drugs Immunomodulators Analgescis

  18. Why report suspected ADRs? • Documentation of ADRs in patients’ records is often poor • Physicians fear that reporting of ADR may put them at risk • Under-reportingis common phenomenon 18

  19. Reporting Methods Spontaneous reporting: (Voluntary) • Doctors, nurses & pharmacists are supplied with forms to record suspected ADRs • Reporting ADRs to National Pharmacovigilance Centre • In UK, this is called ‘Yellow Card system’

  20. Prevention of ADRs • Taking a drug history • Reduce number of prescribed drugs • Remembering that certain patients (elderly, those with liver or renal diseases) more susceptible to ADRs

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